Demonstrating the Efficacy of a Spanish-Language Program for Latino Dementia Caregivers

NCT06747637 | Recruiting

• 1 other identifier: AWD-00008709
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational and skill-building intervention for 226 Spanish-speaking family caregivers in California.

Conditions

Caregiver Burden of People With Dementia

Keywords

wait list control interventional study

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms

  Patient Health Questionnaire 9 item standardized scale: min. to max values=0 to 27; higher values indicate worse outcomes

  baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

• Presence and reaction to memory and behavior problems shown by person with dementia

  Revised Memory and Behavior Problems Checklist standardized scale: 1. Symptom presence (yes/no); min. to max values=0 to 24; higher values indicate worse outcomes 2. Symptom reaction: Include only items with frequency scores of 1 to 4 in the reaction scoring. Compute the mean reaction score by summing reaction scores of these items and then dividing by the number of items included in the sum. the range for each subscale is 0 to 4. Higher values indicate worse outcomes

  baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

• Anxiety symptoms

  Generalized Anxiety Disorder 7 item standardized scale: min. to max values=0 to 24; higher values indicate worse outcomes

  baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

Secondary Outcomes (3)

• Caregiver Mastery

  baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

• Caregiver Competence

  baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

• Caregiver Meaning

  baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline

Study Arms (2)

Group A: Treatment Group Receives the Classes Soon after Randomization

EXPERIMENTAL

The Spanish-language caregiver classes are called Unidos en el Cuidado and are taught online by Alzheimer's Los Angeles. Sessions are provided at no cost and held weekly for about 2 hours.

Other: Skill-building classes

Group B: Wait List Control Group Receives the Classes after a Waiting Period

ACTIVE COMPARATOR

This wait list control group receives the same classes but after a 3-4 week waiting period.

Other: Wait list control group

Interventions

Skill-building classes OTHER

Unidos en el Cuidado is a manualized, multi-family group intervention provided at no cost vis-à-vis videoconferencing or on-site by trained facilitators Sessions are held weekly for 1.5 hours. Class components include caregiver role identity; skills-building; knowledge attainment; attitudinal changes; resource-sharing; practice/role-plays; homework; videos, handouts. Classes will be provided online with some classes offered in the community, if available

Group A: Treatment Group Receives the Classes Soon after Randomization

Wait list control group OTHER

The intervention is the same; the wait period is longer to receive the intervention described in Group A.

Group B: Wait List Control Group Receives the Classes after a Waiting Period

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• identifies with being Hispanic or Latino descent
• speaks and reads Spanish
• dementia family caregivers living (or recently lived) in California or whose care recipient lives (or recently lived) in California
• who identify as women, men, or non-binary,
• age 18 years or older

You may not qualify if:

• Severe sensory or physical conditions that interfere with ongoing participation.

Sponsors & Collaborators

• University of Southern California: lead
• California Department of Public Health: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

RECRUITING

Related Publications (1)

• Griffiths PC, Kovaleva M, Higgins M, Langston AH, Hepburn K. Tele-Savvy: An Online Program for Dementia Caregivers. Am J Alzheimers Dis Other Demen. 2018 Aug;33(5):269-276. doi: 10.1177/1533317518755331. Epub 2018 Mar 16.

  PMID: 29544342 BACKGROUND

Study Officials

• Maria P Aranda, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria P Aranda, PhD

CONTACT

(213) 740-1887; aranda@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 24, 2024
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)